Core Insights - Cellectis reported financial results for Q1 2025, highlighting progress in clinical studies and partnerships, particularly with AstraZeneca [1][2][9] Financial Results - As of March 31, 2025, Cellectis had a cash position of $246 million, down from $264 million at the end of 2024, providing a runway into H2 2027 [10][11] - Consolidated revenues and other income for Q1 2025 were $12.0 million, an increase from $6.5 million in Q1 2024, primarily due to a $5.9 million increase in revenue recognized under the AstraZeneca joint research collaboration agreement [13][14] - R&D expenses for Q1 2025 were $21.9 million, slightly down from $22.3 million in Q1 2024, while SG&A expenses decreased to $4.7 million from $5.1 million [15][16] - The consolidated net loss attributable to shareholders was $18.1 million for Q1 2025, compared to a net income of $5.6 million in Q1 2024 [19][20] Pipeline Highlights - Cellectis is advancing its clinical programs, including the BALLI-01 study for lasme-cel (UCART22) in relapsed or refractory B-cell acute lymphoblastic leukemia, with results expected in Q3 2025 [3][6][7] - The NATHALI-01 study for eti-cel (UCART20x22) in relapsed or refractory B-cell non-Hodgkin lymphoma is ongoing, with readout expected in late 2025 [4][7] Research and Development - Cellectis presented research data on TALEN®-mediated non-viral transgene insertion and TALE base editing at the ASGCT annual meeting, showcasing advancements in gene editing technologies [5][8] - The company is focusing on the development of its pipeline, including manufacturing and clinical trial expenses for UCART22 and UCART20x22 [12] Partnerships - Ongoing R&D activities under the AstraZeneca partnership include three programs: one allogeneic CAR T for hematological malignancies, one for solid tumors, and one in vivo gene therapy for a genetic disorder [9][6]

Core Viewpoint - Cellectis, a clinical-stage biotechnology company, is set to report its financial results for Q1 2025 on May 12, 2025, after the US market closes [1]. Company Overview - Cellectis specializes in developing life-saving cell and gene therapies using its innovative gene-editing platform [2][3]. - The company employs an allogeneic approach for CAR T immunotherapies in oncology, focusing on off-the-shelf and ready-to-use gene-edited CAR T-cells for cancer treatment [2]. - Cellectis is one of the few end-to-end gene editing companies, controlling the entire cell and gene therapy value chain from start to finish through its in-house manufacturing capabilities [2]. Locations and Listings - Cellectis is headquartered in Paris, France, with additional locations in New York and Raleigh, NC [3]. - The company is publicly traded on the Nasdaq Global Market under the ticker CLLS and on Euronext Growth under the ticker ALCLS [3].

Core Insights - Cellectis is presenting research data on TALEN®-mediated non-viral transgene insertion and advancements in genetic editing using TALE base editors at the ASGCT annual meeting in May 2025 [1][13] - The company aims to develop life-saving cell and gene therapies through its innovative gene-editing platform [1][14] Group 1: TALEN®-Mediated Non-Viral Transgene Insertion - Cellectis combines TALEN®-mediated gene editing with non-viral delivery methods to enhance cellular and gene therapies, focusing on gene insertion efficacy and cellular health using single-stranded DNA (ssDNA) [3][4] - This approach addresses challenges associated with traditional viral methods, such as manufacturing constraints and potential genomic toxicities [4][10] - The research indicates that TALEN®-mediated gene editing with non-viral templates can achieve high efficiency in gene insertion in T-cells and hematopoietic stem and progenitor cells (HSPCs) [10] Group 2: TALE Base Editors (TALEB) - TALEB technology allows for high-fidelity C-to-T editing of double-stranded DNA without DNA strand nicking, enhancing the precision of gene editing [7][11] - Cellectis has developed methods to characterize TALEB efficiency and assess factors influencing its activity, including target sequence composition [8][11] - The research shows that TALEB can achieve efficient C-to-T conversion while maintaining specificity, with no detectable off-target editing in primary cells [11][12] Group 3: Future Implications - The advancements in TALEN® and TALEB technologies are expected to provide alternative, efficient, and safe therapeutic options for patients with various diseases, including cancer and autoimmune disorders [6][10] - Cellectis' innovative gene-editing tools are positioned to support novel gene therapy applications, enhancing the control and efficiency of gene editing processes [12][13]

Cellectis Today CLLS Cellectis $1.38 -0.07 (-4.83%) 52-Week Range $1.10 ▼ $3.38 Price Target $7.00 Add to Watchlist Cellectis S.A. NASDAQ: CLLS is a clinical-stage biotechnology company focused on developing 'off-the-shelf' cancer immunotherapies using gene-editing technology. Following a substantial strategic equity investment from AstraZeneca NASDAQ: AZN and a strengthened financial position reported in its full-year 2024 results, Cellectis has entered a potentially pivotal stage in its market narrative. ...

Financial Data and Key Metrics Changes - Cellectis reported a cash position of $264 million as of December 31, 2024, compared to $156 million at the end of 2023, reflecting a $108 million increase primarily due to a $140 million equity investment from AstraZeneca [24][25]. - The company experienced a net cash burn of a little over $100 million in 2024, with a net cash burn of $60 million after accounting for cash inflows from partnerships [70]. Business Line Data and Key Metrics Changes - Cellectis announced the start of research and development activities for three programs under its collaboration with AstraZeneca, including allogeneic CAR T therapies for hematological malignancies and solid tumors, as well as an in vivo gene therapy for a genetic disorder [8][9]. - The company received $47 million under the joint research and collaboration agreement with AstraZeneca, which included $25 million upfront and $22 million for development milestones [24]. Market Data and Key Metrics Changes - Cellectis received Orphan Drug Designation from the FDA for its product candidate UCART22 for the treatment of relapse or refractory acute lymphoblastic leukemia, and a similar designation from the European Commission [13]. - The company is focusing on advancing its core clinical trials, particularly BALLI-01 and NATHALI-01, which target unmet medical needs in hematological malignancies [15][20]. Company Strategy and Development Direction - Cellectis aims to leverage its strategic collaboration with AstraZeneca to shape the future of cell and gene therapies, focusing on developing next-generation genomic medicines [9][15]. - The company plans to continue its efforts on core clinical trials while building its preclinical pipeline, emphasizing the importance of addressing high unmet medical needs [15][28]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing clinical trials and the strategic collaboration with AstraZeneca, highlighting the potential for paradigm shifts in treating hard-to-treat cancers and genetic disorders [28]. - The company anticipates presenting Phase 1 data sets for its clinical product candidates later in 2025, which will inform future development strategies [27][29]. Other Important Information - Cellectis has drawn down the final tranches of a €40 million credit facility from the European Investment Bank, enhancing its cash runway into mid-2027 [11][25]. - The company is actively engaging with regulatory authorities to align on Phase 2 registration strategies for its clinical programs [18][53]. Q&A Session Summary Question: Upcoming data for UCART22 - Management confirmed that a full Phase 1 dose escalation data set will be available in Q3 2025, with additional data to be shared at the ASH Annual Conference [31][34]. Question: Internal bar for success regarding UCART22 - Management expressed confidence in the data seen thus far, particularly for heavily pretreated patients, and ongoing interactions with regulatory authorities are planned [39][40]. Question: Near-term milestones for AstraZeneca collaboration - Management indicated that significant progress has been made, with potential disclosures of comprehensive data sets later in the year [45][46]. Question: Late-stage development strategies for UCART22 - Management is planning interactions with regulatory authorities to establish a clear registration path, with further details expected in Q3 [51][53]. Question: Safety program and registration trials - Management noted that while there are similarities to autologous CAR T trials, the unique nature of allogeneic therapies will be considered in their approach [57][59]. Question: Updates on Servier discussions - Management refrained from commenting on ongoing legal matters related to Servier [75]. Question: Implications of CARGO's CD22 asset discontinuation - Management highlighted the unmet need for non-CD19 CAR T therapies and expressed optimism about the opportunity for UCART20x22 [78][80]. Question: Recent data from ALLO-501A Cema-Cel program - Management acknowledged the encouraging long-term durability data from Allogene, which supports confidence in the allogeneic CAR T approach [88][90]. Question: Enrollment progress for UCART22 and UCART20x22 - Management confirmed that enrollment for UCART22 is on track, with plans for a realistic number of patients for Phase 2 studies [94][96].

Core Insights - Cellectis is advancing its clinical programs, particularly UCART22 and UCART20x22, with significant regulatory designations and expected data readouts in 2025 [1][8][16] - The partnership with AstraZeneca is pivotal, focusing on three key programs in cell and gene therapy, with a strong cash position supporting operations until mid-2027 [2][4][6][25] - Financial results for 2024 show a substantial increase in revenues and a reduced net loss compared to 2023, indicating improved operational performance [30][34][40] Group 1: Clinical Development - UCART22 has received Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) from the FDA, with a Phase 1 dataset and late-stage development strategy expected in Q3 2025 [1][8][16] - The ongoing Phase 1 study of UCART20x22 in relapsed or refractory B-cell non-Hodgkin lymphoma (r/r NHL) is focused on patient enrollment, with results anticipated in late 2025 [1][9] - The BALLI-01 study for UCART22 in relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) is progressing, with the addition of alemtuzumab to the lymphodepletion regimen showing promising results [8][10][16] Group 2: Financial Position - As of December 31, 2024, Cellectis reported a cash position of $264 million, a significant increase from $156 million in 2023, providing a financial runway into mid-2027 [2][30][31] - Revenues for 2024 reached $49.2 million, up from $9.2 million in 2023, primarily due to progress in collaboration with AstraZeneca and other development milestones [34][40] - The net loss attributable to shareholders decreased to $36.8 million in 2024 from $101.1 million in 2023, reflecting improved financial performance [40][41] Group 3: Strategic Partnerships - The collaboration with AstraZeneca includes three programs: an allogeneic CAR T for hematological malignancies, an allogeneic CAR T for solid tumors, and an in vivo gene therapy for a genetic disorder [2][4][25] - AstraZeneca's additional equity investment of $140 million enhances Cellectis' financial stability and supports ongoing research and development efforts [6][23] - The partnership aims to leverage Cellectis' gene editing technology to advance next-generation cell and gene therapies [5][25]

NEW YORK, Feb. 24, 2025 (GLOBE NEWSWIRE) -- Cellectis (the “Company”) (Euronext Growth: ALCLS - NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, showcases an innovative strategy for T cell engineering that leverages the pro-inflammatory properties of interleukin 2 (IL-2) with the objective to enhance CAR T cell efficacy against solid tumors, at the American Association for Cancer Research – Immuno-oncology (AACR- ...

Core Insights - Cellectis is presenting a novel T cell engineering strategy that utilizes interleukin 2 (IL-2) to enhance the efficacy of CAR T cells against solid tumors at the AACR-IO conference [1][2] - The company focuses on developing life-saving cell and gene therapies through its gene-editing platform and allogeneic CAR T immunotherapies [3][4] Company Overview - Cellectis is a clinical-stage biotechnology company that employs a pioneering gene-editing platform to create cell and gene therapies [3] - The company is known for its allogeneic approach to CAR T immunotherapies, offering off-the-shelf and ready-to-use gene-edited CAR T cells for cancer treatment [3] - Cellectis has in-house manufacturing capabilities, making it one of the few companies that control the entire cell and gene therapy value chain [3] Research and Development - The research presented at the conference indicates that CAR-induced expression of a synthetically engineered FAP-IL2v immunocytokine enhances the anti-tumor activity of TALEN-edited allogeneic CAR T cells without the toxicity associated with IL-2 [2][5] - The engineered CAR T cells utilize a CAR-inducible IL-2 variant (IL-2v) that is activated by tumor-specific cues, allowing for localized activity within the tumor microenvironment [5] - This strategy aims to improve CAR T cell expansion and anti-tumor activity while minimizing systemic toxicity typically linked to circulating IL-2 [5]

Core Insights - The article emphasizes the importance of understanding the science behind biotech investments to avoid pitfalls in the industry [1]. Group 1 - The author has a PhD in biochemistry and extensive experience analyzing clinical trials and biotech companies [1]. - The mission is to educate investors on the scientific aspects of biotech businesses to facilitate informed decision-making [1].

Core Insights - Cellectis is presenting pre-clinical data aimed at enhancing CAR T cell activity against solid tumors while minimizing potential toxicity at the Society for Immunotherapy of Cancer's 39th Annual Meeting [1][2] Group 1: Presentation Details - The data will be presented in a poster titled "Breaking barriers in solid tumors with SMART allogeneic CAR T-cells" on November 9th, 2024, from 9:00 am to 8:30 pm ET by Beatriz Aranda-Orgilles [2] - The poster number is 254 [2] Group 2: Challenges in Solid Tumors - Despite the success of CAR T-cell therapies in treating blood cancers, challenges remain in solid tumors due to the hostile tumor microenvironment (TME) which creates an immunosuppressive barrier [2] - Factors such as tumor antigen diversity and low expression of CAR-targeted tumor-associated antigens (TAA) can lead to antigen escape or on-target off-tumor toxicity, complicating therapeutic safety [2] Group 3: Innovative Strategies - Cellectis employs TALEN®-mediated gene editing to generate allogeneic CAR T-cells, repurposing PD-1 function to enhance efficacy and avoid toxicities in solid tumors [3] - The company integrates IL-12 into PD-1 regulatory elements to confine IL-12 to the TME and inactivates TGFBR2 to overcome TGFB1-mediated resistance, enhancing CAR T-cell proliferation and infiltration while reducing tumor burden [4] Group 4: Potential Impact - The data suggests the potential of creating armored allogeneic CAR T-cells with improved activity in immunosuppressive microenvironments, offering a therapeutic option for patients with solid malignancies [5] Group 5: Company Overview - Cellectis is a clinical-stage biotechnology company focused on developing life-saving cell and gene therapies using its gene-editing platform [5] - The company specializes in an allogeneic approach for CAR-T immunotherapies, aiming to provide off-the-shelf, ready-to-use gene-edited CAR T-cells for cancer treatment [5]